DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicants
This action is in response to the Application filed on 04/05/2024.
Claims 1, 4-5, 8, 10-11, 13-17, 19-22, 26, and 85 are pending.
Priority
The Application claims priority to PCT/NZ2022/050127 with filing date 10/06/2022, as well as to Provisional Application 63/262,178 with filing date 10/06/2021, both of which are acknowledged.
Information Disclosure Statements
The Information Disclosure Statements filed on 11/04/2024 and 07/30/2025 have both been fully considered by the examiner.
Claim Objections
Claims 1, 4-5, 8, 10-11, 13-17, 19-22, 26, and 85 are objected to.
Regarding claim 1, in lines 8-9, the limitation of wherein the measurement for the eye of the patient is one of: an eye width and an eye height (emphasis added via underline) is interpreted as requiring both the eye width and height, which is not believed to be Applicant’s intention. Thus, the examiner suggests amending claim 1 to read wherein the measurement for the eye of the patient is one of: an eye width or an eye height (emphasis added via underline). In the interest of compact prosecution, prior art will be applied with the above suggestions in mind.
Regarding claim 26, the same objection applies to lines 9-10.
Regarding claims 4-5, 8, 10-11, 13-17, and 19-22, the same objection applies to these claims, as they depend on claim 1 above.
Regarding claim 85, the same objection applies to this claim, as it depends on claim 26 above.
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-5, 8, 10-11, 13-17, 19-22, 26, and 85 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
Analysis for claim 1 is provided in the following. Claim 1 is reproduced in the following (annotation added):
A method for selecting a mask for a patient for use with a respiratory therapy device, the mask suitable to deliver respiratory therapy to the patient, comprising the steps of:
receiving data representing at least one digital image of a face of a patient;
identifying a predefined reference facial feature appearing in the at least one digital image, the predefined reference facial feature being an eye of the patient;
determining a measurement for the eye of the patient within the at least one digital image, wherein the measurement for the eye of the patient is one of: an eye width and an eye height;
allocating a predefined dimension to the measurement,
and determining a scaling factor for the at least one digital image, the scaling factor being a ratio between the measurement and the predefined dimension;
identifying a further facial feature in the at least one digital image;
determining a measurement of the further facial feature in the at least one digital image;
and calculating a calculated dimension of the further facial feature using the scaling factor and the measurement of the further facial feature;
and, comparing the calculated dimension of the further facial feature with mask sizing data associated with patient masks and selecting a mask for the patient in dependence on the comparison.
Step 1: Does the claim belong to one of the statutory categories? Claim 1 is directed to a process, which is a statutory category of invention (YES).
Step 2A Prong One: Does the claim recite a judicial exception? Steps c-d and f-j can be regarded as reciting mental processes, such as observations, evaluations, judgements, or opinions, that can be practically performed in the human mind. Part c recites identifying facial features of an eye of the patient in an image, and step d recites determining measurements of the width or height of the eye. Step f recites determining a ratio between the eye measurement and a predefined dimension. Steps g and h recite similar identifications and determinations to steps c and d, respectively. Step i recites calculating a calculated dimension of a further facial feature using the scaling factor and a measurement of said feature. Finally, step j recites comparing the calculated dimension with mask sizing data and selecting a mask based on the comparison. The examiner notes that steps d, f, h, and i include measurements and calculations that can additionally be practically performed by a human using pen and paper additionally to in the human mind (YES).
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? Part a is a preamble describing the method. Part b describes mere data gathering. Part e recites allocating a predefined dimension to the measurement [of the width or height of the eye], which does not integrate the judicial exceptions into a practical application. Although this step cannot be performed in the human mind, its only use in the claim is to determine the scaling factor, which is ultimately applied to perform mental processes (NO).
Step 2B: Does the claim as a whole amount to significantly more than the recited exception? The claim as a whole recites mere data gathering to perform a sequence of practically-performed mental processes using said data.
The examiner notes that step j does not use the recited judicial exceptions to affect a particular treatment or prophylaxis for a disease or medical condition. See MPEP 2106.04(d)(2), which states that such limitations “must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition.” The passage considers the example limitation of “prescribing a topical steroid to a patient with eczema” to not be a positive limitation, as it “does not require that the steroid actually be used by or on the patient.” The examiner considers step j analogous to this example, as only selecting a mask for use by the patient does not require said mask actually being used by or on the patient.
The examiner notes that the claim does not appear to apply the judicial exceptions with, or by the use of, a particular machine. Although the preamble of step a recites “selecting a mask for a patient for use with a respiratory therapy device”, this reads as an intended use limitation; no actual respiratory therapy device is required for someone performing mental processes to infringe on the claim (NO). Claim 1 is not eligible.
Similar analysis is applicable to independent claim 26, which additionally recites a computerized system at a high level of generality, which does not integrate the judicial exceptions into a practical application. Like claim 1 above, claim 26 recites “a system for selecting a mask for a patient for use with a respiratory therapy device”, which still reads as an intended use limitation. Claim 26 is not eligible.
Claim 4 narrows the identification of the eye to include identifying at least two facial landmarks, which can still be practically performed in the human mind. Claim 4 is not eligible.
Claim 5 narrows the at least two facial landmarks to specific species. Claim 5 is not eligible.
Claim 8 narrows the identification of the further facial feature to include identifying at least two facial landmarks, which can still be practically performed in the human mind. Claim 8 is not eligible.
Claim 10 narrows the measurement of facial features to include calculating a number of pixels between the landmarks, which can still be practically performed in the human mind or by a human using pen and paper. Claim 10 is not eligible.
Claim 11 narrows the eye measurement to include identifying two eyes, measuring each eye, and averaging these measurements, which can still be practically performed in the human mind or by a human using pen and paper. Claim 11 is not eligible.
Claim 13 recites determining at least one attribute of the image and comparing it to predefined attribute criteria, and further conditionally performing at least one of the steps of the method based on said comparison, which can still be practically performed in the human mind. Claim 13 is not eligible.
Claims 14-15 narrow the attributes and criteria to specific species. Claims 14-15 are not eligible.
Claim 16 recites mere data output. Claim 16 is not eligible.
Claim 17 narrows the calculation of the calculated dimension to include calculating for multiple images and averaging the calculation results, which can still be practically performed in the human mind or by a human using pen and paper. Claim 17 is not eligible.
Claim 19 recites determining at least one attribute of the images, and comparing them to predefined criteria, and, only calculating the average dimension using images that met the predefined criteria, which can still be practically performed in the human mind or by a human using pen and paper. Claim 19 is not eligible.
Claim 20 recites determining a mask category for the patient, which can be practically performed in the human mind. Claim 20 is not eligible.
Claim 21 recites presenting a question to the patient and receiving a response, which is regarded as mere data gathering. Claim 21 further recites determining a mask category based on the response, which can be practically performed in the human mind. Claim 21 is not eligible.
Claim 22 recites that the further facial feature is selected based on the determined mask category, which can be practically performed in the human mind. Claim 22 is not eligible.
Claim 85 recites devices for performing mere data gathering and output. Claim 85 is not eligible.
The examiner additionally notes that claim 26 recites “a memory for storing mask sizing data associated with patient masks”, which can read on both transitory and non-transitory memories. However, the claim recites that the system comprises both a processor and this memory, as well as that the processor performs comparisons using the data stored on the memory. Thus, the recited memory is incorporated into a physical structure and avoids a 35 U.S.C. 101 rejection for being directed to non-statutory subject matter.
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-5, 8, 10-11, 13-14, 16, 20, 22, 26, and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Morrell et al. (U.S. Publ. US-2023/0103129-A1) in view of Khadem et al. (U.S. Publ. US-2022/0198727-A1).
Regarding claim 1, Morrell discloses a method for selecting a mask for a patient for use with a respiratory therapy device (see figures 4-5 and 11), the mask suitable to deliver respiratory therapy to the patient (see paragraphs 0001-0004), comprising the steps of:
receiving data representing at least one digital image of a face of a patient (see paragraph 0075, where a stream or sequence of images are received);
identifying a predefined reference facial feature appearing in the at least one digital image, the predefined reference facial feature being an eye of the patient (see figure 4, step 407, 410, 413 and paragraph 0093, where coordinates of eye landmarks are identified);
determining a measurement for the eye of the patient within the at least one digital image (see figure 5, steps 413, 320 and paragraphs 0100-0101, where the eye coordinates are used to measure the horizontal or vertical iris diameters of the eyes),
allocating a predefined dimension to the measurement, and determining a scaling factor for the at least one digital image, the scaling factor being a ratio between the measurement and the predefined dimension (see figure 5, step 507 and paragraphs 0100-0101, where a scaling factor is determined as a ratio between the pixel diameter of the iris and a predetermined fixed value/predefined dimension representing a known physical measurement, such as millimeters);
identifying a further facial feature in the at least one digital image (see figure 5, step 510, 515 and paragraphs 0102-0103, where facial landmarks for the nose and other facial features are obtained);
determining a measurement of the further facial feature in the at least one digital image; and calculating a calculated dimension of the further facial feature using the scaling factor and the measurement of the further facial feature (see figure 5, steps 512, 517, 520 and paragraphs 0101-0105, where the scaling factor is applied to pixel measurements of nose width, nose depth, and face height to convert them to physical measurements);
and, comparing the calculated dimension of the further facial feature with mask sizing data associated with patient masks and selecting a mask for the patient in dependence on the comparison (see figure 5, step 520; figure 11, step 1130 and paragraphs 0111, 0175-0176, and 0201, where the determined facial measurements can be used to select a mask for the patient, such as by comparing to preset dimensions for pre-designed masks).
Morrell fails to disclose determining a measurement for the eye of the patient within the at least one digital image, wherein the measurement for the eye of the patient is one of: an eye width and an eye height (emphasis added via underline). In other words, the only deficiency of Morrell regarding claim 1 is that Morrell uses iris width as the reference distance for calculating the scaling factor, instead of eye width.
Pertaining to the same field of endeavor, Khadem discloses determining a measurement for the eye of the patient within the at least one digital image, wherein the measurement for the eye of the patient is one of: an eye width and an eye height (see figure 3 and paragraphs 0026-0028, where the number of pixels in an outline of a hairstyle can be referenced to a reference distance, such as iris width or eye width, to measure a "hair fullness score"; paragraphs 0020 and 0023 specify that the hair fullness score can involve measuring distances across the hair and/or face).
Morrell and Khadem are considered analogous art, as they are both directed to facial image analysis using reference distances. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Khadem into Morrell because using reference distances, such as eye width, can compensate for varying distances between the camera and subject when measuring physical dimensions (see Khadem paragraph 0019).
Regarding claim 4, Morrell in view of Khadem discloses wherein the step of identifying an eye of the patient in the at least one digital image is performed by identifying at least two predefined facial landmarks, being anthropometric features of the face of the patient, in the at least one digital image associated with the eye (see Morrell paragraph 0093, where landmarks can include the top/bottom of each eye, inner/outer corners of each eye, and edges of the pupil/iris of each eye).
Regarding claim 5, Morrell in view of Khadem discloses wherein the at least two predefined facial landmarks in the at least one digital image are corners of the eye or a medial canthus and a lateral canthus (see Morrell paragraph 0093, where landmarks can include the top/bottom of each eye, inner/outer corners of each eye, and edges of the pupil/iris of each eye).
Regarding claim 8, Morrell in view of Khadem discloses wherein the further facial feature is identified by identifying at least two facial landmarks associated with the further facial feature (see Morrell paragraphs 0049, 0062, and 0095, where identification of the nose, mouth, and face height involve multiple landmarks, such as the sellion, supramention, nose tip, bottom of the chin, etc.).
Regarding claim 10, Morrell in view of Khadem discloses wherein the step of determining a measurement of a facial feature is performed by calculating a number of pixels of the at least one digital image between at least two facial landmarks in the at least one digital image associated with the facial feature (see Morrell paragraph 0049, where, for example, the facial height is measured as the distance between the sellion and supramenton).
Regarding claim 11, Morrell in view of Khadem discloses wherein the step of determining the measurement for the eye of the patient within the at least one digital image is performed by identifying two eyes of the patient within the at least one digital image and calculating a measurement for each eye and calculating an average measurement for the two eyes (see Morrell paragraph 0101, where both the left and right eyes can be identified, their iris diameters measured, and then the two values are averaged to determine the scaling factor).
Regarding claim 13, Morrell in view of Khadem discloses determining at least one attribute of the at least one digital image; comparing the at least one attribute with predefined attribute criteria; and determining whether the at least one attribute meets the predefined attribute criteria (see Morrell see figure 4, steps 330, 405 and paragraphs 0088-0091, where each image is analyzed to determine if they depict desired facial angles, as well as the absence of glasses on the patient's face);
wherein at least one of the steps of: identifying an eye of the patient; determining a measurement for the eye of the patient; allocating a predefined dimension to the measurement; determining a scaling factor; identifying a further facial feature; determining a measurement of the further facial feature; calculating a calculated dimension of the further facial feature; and selecting a mask for the patient is performed in dependence on the at least one attribute meeting the predefined attribute criteria (Morrell paragraphs 0031 and 0091 specify that only images that pass the above criteria are further processed by the method).
Regarding claim 14, Morrell in view of Khadem discloses wherein the at least one attribute comprises at least one of: an angle of the face of the patient within the at least one digital image, the angle being at least one of a pitch angle, a yaw angle or a roll angle; a focal length of the at least one digital image; depth of the face of the patient in the at least one digital image; and at least one predefined landmark being identified in the at least one digital image (see Morrell paragraphs 0031 and 0080, where the criteria can include a facial tilt in any direction within a specified angle threshold).
Regarding claim 16, Morrell in view of Khadem discloses providing feedback relating to whether the at least one attribute meets the predefined attribute criteria (see Morrell paragraphs 0054 and 0059).
Regarding claim 20, Morrell in view of Khadem discloses determining a determined mask category for the patient (see Morrell paragraph 0201).
Regarding claim 22, Morrell in view of Khadem discloses wherein the further facial feature is selected from a plurality of facial features in dependence on the determined mask category (see Morrell paragraph 0034, where the particular facial measurements that are determined and used can vary depending on the particular task or mask type being evaluated),
wherein different mask categories have different relationships between mask sizing data and dimensions of facial features, and wherein the mask sizing data for the determined mask category includes data relating to the selected further facial feature of the plurality of facial features (see Morrell paragraph 0201, where each pre-designed mask is associated with a set of facial measurements, such as facial height and nose depth).
Regarding claim 26, Morrell discloses a system for selecting a mask for a patient for use with a respiratory therapy device (see figure 14), the mask suitable to deliver respiratory therapy to the patient (see paragraphs 0001-0004), the system comprising: a processor configured to (see figure 14, CPU 1405).
Morrell also discloses a memory for storing mask sizing data associated with patient masks (see figure 14, memory 1410).
The remainder of the claim recites that the processor performs steps identical to those of claim 1. Therefore, Morrell in view of Khadem discloses claim 26 as applied to claim 1 above.
Regarding claim 85, Morrell in view of Khadem discloses wherein the system comprises a mobile communications device (see Morrell paragraph 0038), the mobile communications device further comprising: an image capture device for capturing digital image data (see Morrell paragraph 0051); and a user interface to display data related to the at least one selected mask (see Morrell paragraph 0055).
Claims 15, 17, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Morrell et al. (U.S. Publ. US-2023/0103129-A1) in view of Khadem et al. (U.S. Publ. US-2022/0198727-A1), and further in view of Fu et al. (U.S. Publ. US-2018/0117272-A1).
Regarding claim 15, Morrell in view of Khadem fails to disclose the limitations of claim 15.
Pertaining to the same field of endeavor, Fu discloses wherein the at least one attribute is a pitch angle, the predefined attribute criteria being an angle between 0 to +-6 degrees with respect to a plane of the at least one digital image (see paragraph 0161, where the tilt angle can be a tilt in any direction within +/- 1, 3, or 5 degrees).
Morrell and Fu are considered analogous art, as they are both directed to facial image analysis using reference distances for mask selection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Fu into Morrell and Khadem because doing so increases measurement accuracy (see Fu paragraph 0161).
Regarding claim 17, Morrell in view of Khadem fails to disclose the limitations of claim 17.
Pertaining to the same field of endeavor, Fu discloses wherein the step of calculating the calculated dimension of the further facial feature is performed for multiple images of the at least one digital image to produce multiple calculated dimensions (see figure 6C, steps 610-670 and paragraph 0171, where the steps can be repeated for a plurality of captured images),
the method comprising the further step of calculating an average dimension of the further facial feature across at least a predetermined number of the multiple images (see figure 6C, step 680 and paragraph 0172);
and using the average dimension to compare with the mask sizing data (see figure 6D, steps 730, 732 and paragraphs 0176-0177, where the final facial feature measurements are compared to data records of patient interfaces/masks to select a mask of best fit).
Morrell and Fu are considered analogous art, as they are both directed to facial image analysis using reference distances for mask selection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Fu into Morrell and Khadem because averaging the measurements across multiple images increases accuracy (see Fu paragraph 0163).
Regarding claim 19, Morrell in view of Khadem fails to disclose the limitations of claim 19.
Pertaining to the same field of endeavor, Fu discloses determining at least one attribute of the multiple images; comparing the at least one attribute with predefined attribute criteria; and determining whether the at least one attribute meets the predefined attribute criteria (see figure 6A, step 440 and paragraph 0160, where the image is analyzed to determine if the reference feature is fully depicted; see figure 6A, step 450 and paragraph 0161, where the tilt of the device and thus of the image are obtained, and compared to a threshold value to determine if the tilt is acceptable);
wherein the average dimension is calculated across the multiple images which meet the predefined attribute criteria (see figures 6A-6D and paragraph 0162, where all subsequent steps to those of figure 6A are only performed if the alignment parameters and any other required conditions are satisfied, thus only images that satisfy the criteria are used for the averaging process).
Morrell and Fu are considered analogous art, as they are both directed to facial image analysis using reference distances for mask selection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Fu into Morrell and Khadem because averaging the measurements across multiple images increases accuracy (see Fu paragraph 0163).
Regarding claim 21, Morrell in view of Khadem fails to disclose the limitations of claim 21.
Pertaining to the same field of endeavor, Fu discloses presenting at least one patient question to the patient; receiving at least one patient response to the at least one patient question; and determining a determined mask category for the patient in dependence on the at least one patient response (see paragraph 0149, where the patient can be prompted with a set of questions, where the responses can be used to determine the patient interface/mask type).
Morrell and Fu are considered analogous art, as they are both directed to facial image analysis using reference distances for mask selection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Fu into Morrell and Khadem because doing so allows for further mask determination based on patient input (see Fu paragraph 0149).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS JOHN HELCO whose telephone number is (703)756-5539. The examiner can normally be reached on Monday-Friday from 9:00 AM to 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella, can be reached at telephone number 571-272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS JOHN HELCO/Examiner, Art Unit 2667
/MATTHEW C BELLA/Supervisory Patent Examiner, Art Unit 2667